CONFERENCE EXPORT REFORM BILL PROVIDES HHS WITH DETAILED CRITERIA FOR EXPANDING "TIER-ONE" LIST OF COUNTRIES; FDA CERTIFICATION FEE INCLUDED
This article was originally published in The Gray Sheet
Executive Summary
Export reform language reported out of conference March 27 would allow HHS to expand the bill's list of 24 industrialized countries to which unapproved devices and drugs could be exported without FDA clearance.
You may also be interested in...
Executives On The Move: Changes At The Top At Enzolytics, Dyne Therapeutics And Seres Therapeutics
Recent moves in the industry include new chief financial officers at LENZ Therapeutics and Botanix Pharmaceuticals, plus new chief medical officers at Vigil Neuroscience and Voyager Therapeutics.
Israel's Gamida Cell Survives By Selling To Lender
Having finally secured US approval for Omisirge, Gamida was hoping to bag a strategic partner for the cell therapy. A year on, no suitable partner has been identified and the firm is delisting from the NASDAQ and going private.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.